The ISO 13485 standard is an international quality management system standard that is specifically defined in the field of medical devices and is intended for organizations supplying medical devices and providing services related to medical devices, regardless of the type of activity or the size of the organization, in order to achieve regulations and display Commitment of responsibility helps in the safety and quality of medical equipment. The importance of implementing the ISO 13485 standard in ensuring the safety and effectiveness of the product is so significant that the regulations of the European Union in ensuring the quality of medical devices, medical diagnostic devices (IVD) and active implantable medical devices (AIMD) are aligned with this standard. . Also, the regulatory laws of most countries with an opinion on the regulation of medical devices are in accordance with the above standard. In Iran, like many countries in the world, compliance with the requirements of ISO 13485 is mandatory for the production of medical equipment. Obviously, every organization can produce and supply its products to consumers in different ways, and there are also different ways to implement the requirements and establish the quality management system in accordance with the ISO 13485 standard and maintain it.